This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Adding b1+rms scanner limits to support 1. 5t full body mri conditional labeling for ipg1000/1500/2000/2500 with surpass surgical and percutaneous leads to enhance the safety of the senza scs system. Also, you requested approval for some other minor additional administration clarifications added in the manual based on customer feedback on the readability of the manual.
| Device | Senza Spinal Cord Stimulation (SCS) System |
| Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Applicant | NEVRO CORPORATION |
| Date Received | 2020-04-27 |
| Decision Date | 2020-05-26 |
| PMA | P130022 |
| Supplement | S033 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEVRO CORPORATION 1800 Bridge Parkway redwood City, CA 94065 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130022 | Original Filing | |
| S047 | 2022-11-22 | 30-day Notice |
| S046 | 2022-04-15 | Special (immediate Track) |
| S045 | ||
| S044 | ||
| S043 | ||
| S042 | 2021-07-22 | Panel Track |
| S041 | 2021-02-12 | Real-time Process |
| S040 | 2021-02-09 | Normal 180 Day Track |
| S039 | ||
| S038 | 2020-11-09 | Real-time Process |
| S037 | ||
| S036 | ||
| S035 | ||
| S034 | ||
| S033 | 2020-04-27 | Special (immediate Track) |
| S032 | ||
| S031 | 2020-01-03 | Real-time Process |
| S030 | ||
| S029 | ||
| S028 | 2019-08-12 | Normal 180 Day Track |
| S027 | 2019-08-12 | Real-time Process |
| S026 | 2019-07-29 | Real-time Process |
| S025 | 2019-05-24 | Real-time Process |
| S024 | ||
| S023 | 2019-04-19 | Real-time Process |
| S022 | ||
| S021 | ||
| S020 | ||
| S019 | 2018-08-13 | Normal 180 Day Track |
| S018 | 2018-07-23 | Real-time Process |
| S017 | 2017-09-12 | Normal 180 Day Track No User Fee |
| S016 | 2017-09-06 | 30-day Notice |
| S015 | 2017-07-14 | 30-day Notice |
| S014 | 2017-07-03 | Normal 180 Day Track |
| S013 | 2017-05-16 | Normal 180 Day Track |
| S012 | 2017-02-01 | 30-day Notice |
| S011 | 2016-12-19 | 30-day Notice |
| S010 | 2016-10-20 | Normal 180 Day Track No User Fee |
| S009 | 2016-09-26 | Real-time Process |
| S008 | 2016-05-02 | Real-time Process |
| S007 | 2016-04-11 | 135 Review Track For 30-day Notice |
| S006 | 2016-03-16 | 30-day Notice |
| S005 | 2016-03-16 | Real-time Process |
| S004 | 2015-11-23 | Normal 180 Day Track |
| S003 | ||
| S002 | 2015-09-04 | Real-time Process |
| S001 | 2015-09-02 | 30-day Notice |